Development and Validation of High Performance Thin Layer Chromatographic Method for the Estimation of Voglibose in Bulk and Tablet Dosage Forms Estimation of Voglibose by HPTLC
Iranian Journal of Pharmaceutical Sciences,
Vol. 18 No. 4 (2022),
1 October 2022
,
Page 308-315
Abstract
A simple, fast, specific, precise, and accurate High-Performance Thin Layer Chromatographic method (HPTLC) was developed and validated for the estimation of Voglibose in bulk and pharmaceutical formulations. The chromatographic separation was carried out on precoated silica gel 60F254 aluminum plates using a mixture of acetonitrile: methanol: ammonia (15:4:0.1 % V/V/V) as mobile phase and densitometric evaluation of spots was carried out at 284 nm using Camag TLC scanner III with CATS 1.3.4 version software. The experimental parameters like band size of the spot application, chamber saturation time, solvent front migration, slit width, etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with an Rf value of 0.66±0.03. The accuracy and repeatability of the proposed method were ascertained by evaluating various validation parameters like linearity (100 to 450 ng/spot), precision (intra-day % RSD 0.17 to 0.69, inter-day % RSD 0.20 to 0.29), accuracy (96.24±0.20), and specificity according to ICH guidelines. The limits of detection and quantification were 40ng/spot and 100 ng/spot respectively. HPTLC method provides a faster and cost-effective quantitative control for routine analysis of Voglibose in its formulation.
- Voglibose
- HPTLC
- Densitometric estimation
- Method development
- Validation
How to Cite
References
Yamasaki Y, Katakami N, Hayaishi R, Matsuhisa M, Kajimoto Y, Kosugi K, Hatono M, Hori M.: Alpha-Glucosidase inhibitor reduces the progression of carotid intima-media thickness, Diabetes Res. Clin. Practices, 2005, 67 (3), 204-210.
Watanabe K, Uchino H, Ohmura C, Tanaka Y, Onuma T, Kawamori R.: Different effects of two alpha-glucosidase inhibitors, acarbose and voglibose, on serum 1,5-anhydroglucitol (1,5AG) level, J. Diabetes Complicat, 2004, 18 (3), 183-186.
Vichayanrat A, Ploybutr S, Tunlakit M, Watanakejorn P.: Efficacy and safety of voglibose in comparison with acarbose in type 2 diabetic patients, Diabetes Res. Clin. Practices, 2002, 55 (2), 99-103.
Zhang H, Sun C.R, Ishurd O, Pan Y.J., Ding L.S.: Determination of the structures of four new isomeric cyclitols, Carbohydr. Res, 2004, 339 (11), 2027-2030.
Chan X, Zheng Y, Shen Y.: Efficacy and safety of vildagliptin and voglibose in Japanese patients with type 2 diabetes a 12-week, randomized, double-blind, active-controlled study, Curr. Med. Chem, 2006, 13 (2), 109-116.
Rethfeld I, Blaschke G.: Analysis of the antidiabetic drug acarbose by capillary electrophoresis, J. Chromatogr. B, 1997, 700 (1-2), 249-253.
Kato T, Kinoshita T.: Fluorometry of saccharides by HPLC using taurine-periodate reagent, Bunseki Kagaku, 1996, 35 (10), 869-874.
International Conference on Harmonization Guideline on Validation of Analytical Procedures. Text Methodol.: Q2(R1), 2005.
F. Register., International Conference on Harmonization, Draft Revised Guidance on Q1A(R) Stability Resting of New Drug Substances and Products, Inc. 65 (2000), 21446.
International Conference on Harmonization Guidelines on Stability Testing of New Drug Substances and Products. Text Methodol.: Q1 A (R2), 2003
- Abstract Viewed: 220 times
- IJPS- Volume 18- Issue 4- P. 308-315 Downloaded: 126 times